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Substance Dependent Teens - Impact of Treating Depression Study 1 - 1

National Institutes of Health (NIH) logo

National Institutes of Health (NIH)

Status and phase

Completed
Phase 4

Conditions

Substance-Related Disorders
Marijuana Abuse
Alcohol-Related Disorders

Treatments

Drug: placebo + CBT
Drug: Fluoxetine + outpatient cognitive behavioral therapy
Drug: fluoxetine

Study type

Interventional

Funder types

NIH

Identifiers

NCT00061113
NIDA-13176-1
R01-13176-1

Details and patient eligibility

About

The purpose of this study is to evaluate the impact of treating depression on substance dependent teens.

Full description

The primary study aim is to determine whether fluoxetine + CBT is a more effective treatment than placebo + CBT for substance outcomes, depression, and behavior problems. The current community standard of care often withholds pharmacotherapy for depression in substance abusing adolescents, since it is often assumed that their depressions may remit with SUD treatment alone. However, this is an untested hypothesis in adolescents and one that we propose to test in the current study.

Enrollment

126 patients

Sex

All

Ages

13 to 19 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Must have DSM IV non bipolar Major Depressive disorder (by clinical interview), DSM IV Conduct Disorder, and Non-Tobacco Substance Disorder.

Exclusion criteria

  • History of or current psychosis, history of psychotic depression, bipolar disorder I or II, family history of first degree relative with bipolar I, lifetime history of non-substance induced Mania/Hypomania
  • Unstable chronic or serious medical illness
  • Currently pregnant
  • Take psychotrophic medication, past 2 months: medication or treatment for depression, clinically significant laboratory abnormality

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Quadruple Blind

126 participants in 2 patient groups, including a placebo group

1
Active Comparator group
Description:
fluoxetine + CBT
Treatment:
Drug: fluoxetine
Drug: Fluoxetine + outpatient cognitive behavioral therapy
2
Placebo Comparator group
Description:
placebo + CBT
Treatment:
Drug: placebo + CBT

Trial contacts and locations

2

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Data sourced from clinicaltrials.gov

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